Manager, Regulatory Affairs

The Manager, Regulatory Affairs will oversee the day to day regulatory submissions for projects outside of the US and will aid in US efforts as needed. May directly interface with regulatory authorities on specific projects or products to ensure the company is adhering to all applicable government regulations and successfully manage multiple projects simultaneously while adapting to changing project priorities.

Duties and Responsibilities Include But Are Not Limited To:

• Prepare and oversee submissions and interactions with health authorities outside of the US, including investigational, marketing, and/or post-licensure regulatory submissions (including INDs/CTAs, IND amendments, annual reports, BLA/NDA/MAAs, BLA/NDA supplements, etc.) in accordance with the regulations and relevant guidelines (domestic and international).
• Participate in study teams to manage Regulatory activities related to product development.
• Assist other departments and submission authors in writing and editing submissions, in compliance with departmental and regulatory standards.
• Research and provide analysis of current regulations and guidance
• Create and manage departmental SOPs and guidelines.
• Produce high quality regulatory submissions in paper or using electronic publishing systems.
• Responsible for assigned activities with the project team.
• Perform other duties as required.

Desired Knowledge and Abilities:

• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Experience with electronic filing (eCTD) and database management abilities.
• Experience with documentation systems and with document review and auditing.
• Strong verbal and written communication skills.
• Excellent computer skills.
• Strong knowledge of current US and ex-US regulatory guidelines, including GCP, GLP, and GMP.
• Ability to work well in a deadline-driven environment.
• Capable of supporting multiple projects simultaneously.

Education and Experience:

• Bachelor's degree Life/Health Sciences.
• Minimum of 5 years of experience in pharmaceutical / biotech industry, with a minimum of 3 years of experience in Regulatory Strategy outside of the US.
• Experience with Asia Pacific (China) regulatory submissions and health authority interactions a plus.
• CMC Biologics experience within biotherapeutics development/GMP operations.
• Oncology drug development experience preferred; gene therapy experience a plus.